Retaining element for an implant and ampoule for preserving said implant

ABSTRACT

The proposal is for a holding element ( 100 ) which can be screwed into the internally threaded bore ( 14 ) of the implant ( 1 ) even during production of the latter and can thus be used to grip or hold the implant for the following production phases. Furthermore, the holding element ( 100 ) serves to fix an implant ( 1 ), which is screwed thereto, inside an ampoule ( 200 ) and for the application of a screwing-in tool for implantation. The particular feature of the ampoule ( 200 ) lies in the fact that it has a large-area, lateral cutout ( 231 ) in the casing and also a fixing part ( 210 ) for accommodating the holding element ( 100 ) in a clamped manner. The implant ( 1 ) can thus be pulled laterally out of the ampoule ( 200 ). The devices facilitate handling of the implant ( 1 ) during production and insertion into the bone.

APPLICATION AREA OF THE INVENTION

The present invention relates to a holding element for an implant,primarily in screw or cylinder form. A first type of implant which maybe considered has a bore which at least in principle emerges axially onthe implant head and has an internally threaded section. The mouth ofthe bore is surrounded by an implant shoulder, which forms the upper endof the implant. The second type of implant which is suitable has asegment which projects above the implant shoulder and has an internallythreaded section. The segment has a predominantly polygonal or conicalouter contour. Such implants are used, for example, in the dental sectoror in bone surgery. The implant is intended to be inserted—i.e. screwedor pressed—into a receiving bore which has been prepared in the bone.This depends on whether the receiving bore has an internal screw threador the implant has a self-tapping thread or the implant has no thread atall. Furthermore, the invention relates to an ampoule in which theimplant is stored.

The holding element can be employed during a number of production phasesof the implants in order to prepare them prior to the surgicalintervention, and can also be employed directly during implantation. Theprimary application area of the invention is where the implants, forexample for reasons of the sterile operating procedure required, mustnot be taken hold of at least directly with the hands, and where it isimportant to hold the implants secure.

The holding element can also be used inside a special ampoule whichserves to transport and store the implant. During the surgicalintervention, the implant can be removed from the ampoule under sterileconditions using an attached tool and then, by means of this tool, canbe inserted into the receiving bore in the bone. To ensure a sterileoperating procedure, the ampoule is stored in a secondary capsule untilthe start of the intervention.

PRIOR ART

The first type of implant mentioned is described, for example, in themonograph by SCHROEDER/SUTTER/BUSER/KREKELER: Oral Implantology, GeorgThieme Verlag Stuttgart and New York, 2nd Edn., 1996, pp 124-143, and inWO-A-96 19947. The second type of implant, having the outer segmentwhich projects above the implant shoulder, is shown, for example, inWO-A-91 10410 and U.S. Pat. No. 5,538,428. Various manipulation membersare used for handling these implants, the implants being taken hold ofin a positively and/or non-positively locking manner.

The following situation exists with regard to ampoules where sterileconditions are to be maintained: in principle, the ampoules can also bedivided into two types. In a first type, the implant stored in theampoule is connected to the cover, which directly or indirectlyfunctions at the same time as a screwing-in tool and is used at least tosome extent to screw in the implant. According to U.S. Pat. No.4,856,648, in its most simple form the cover has an extension with anon-rotationally symmetrical engagement contour which interacts with acomplementary contour on the implant head. It is known from U.S. Pat.Nos. 5, 312,254 and 5,538,428 to introduce a connecting element betweenthe cover and the implant, which connecting element transmits therotational screwing movement. U.S. Pat. No. 5,062,800 has disclosed anampoule where the cover represents the connecting element for thescrewing-in tool. These ampoules are to some extent very expensive, asthe tool components are generally only used once. Furthermore, handlingthese ampoules often requires a relatively large number of operations,and in addition external screwing-in tools are also required. Finally,it is doubtful whether the implants are gripped sufficiently reliably bythe screw covers or the connecting elements.

In the case of the second type, the implant arranged in the ampoule hasto be taken hold of and screwed in using an external tool. The presentinvention relates to this type of ampoule. EP-B-0 231 730 discloses asimple variant where the implant is positioned in a sleeve and theimplant head projects above and closes off one end of the sleeve. Thesleeve is fused into a glass ampoule, which has constrictions and aninternal spring. The implant head is supported against the spring, andthe sleeve is fixed inside the constrictions, one constriction at leastpartially closing off the bottom of the sleeve. Suitable external toolsare used to grip the implant, while on the ampoule itself there are nomeans whatsoever which facilitate and make more reliable the removal ofthe implant from the ampoule and transportation to the site ofimplantation.

Such a type of ampoule with sterile conditions is also disclosed bySCHROEDER/SUTTER/BUSER/KREKELER, loc. cit., pp. 219-221. Thecapsule-like ampoule has a removable cover and a partition which extendsperpendicular to the longitudinal axis, close to the cover. In thispartition, there is an axial passage in which a bearing ring rests, inwhich the head of the implant is positioned, while the apical part ofthe implant projects into the ampoule. In order to take hold of theimplant, a lockable screwing-in tool is attached, the threaded mandrelof which is screwed into the axial threaded bore, which is in the formof a blind bore and is present in the implant head. Having been screwedonto the screwing-in tool, the implant is then removed from the ampoule.The implant is then positioned in the hole in the bone, spanners beingattached to the screwing-in tool. Finally, the lock between the implantand the screwing-in tool has to be released again, so that thescrewing-in tool can be unscrewed. This handling method requiresnumerous operations, a plurality of instruments and particular care andskill on the part of the surgeon. The instruments attached while theimplants are being introduced into the bone are unsuitable asmanipulating members during the overall production process of theimplants; separate holders have to be used for this purpose.

OBJECT OF THE INVENTION

In view of the abovementioned drawbacks of the devices which have beenused to date to grip and hold implants of the two types mentioned above,the problem underlying the invention is that of perfecting such devices.It is desired to make the connection between the implant and the holdingelement more efficient in production terms, more widely usable, reliableand also, ultimately, able to be released without problems. In thepreparatory phase of the surgical intervention and also during theintervention, it is necessary to ensure that the implants used canalways be guided reliably, can in no way become loose and uncontrollableand that the sterility requirements are fulfilled. The holding elementshould significantly facilitate removal of the implant from the ampouleusing the attached screwing-in tool and insertion of the implant intothe bone. With regard to the ampoule, the object is to develop itfurther in such a manner that the implant is held reliably therein andcan be removed in an uncomplicated manner and under sterile conditionsusing a screwing-in tool which is simple to attach. If the implant isremoved from the ampoule correctly, it is intended that the risk ofcontact between implant and ampoule should in principle be ruled out, soas to avoid contamination or damage to the intra-ossal implant surface.It is to be envisaged that the ampoule can be inserted into aconventional external capsule for storage and transportation. Moreover,it should be possible to produce the ampoule as a disposable item in amaterial-saving and, overall, cost-effective manner.

OVERVIEW OF THE INVENTION

The holding element comprises a sleeve part and a rotatable screw whichprojects through the sleeve part and can move axially to a limitedextent. The sleeve part has, at the bottom, a cylindrical shoulder partwhich ends with a mating shoulder which is directed downwards and iscomplementary to the implant shoulder. An upwardly directed externalpolygon segment extends above the shoulder part. An axial bore allowingthe passage of the shaft of the screw runs through the sleeve part. Inan advantageous refinement, the axial bore has an internally threadedsection.

The screw comprises the lower screw shank, the adjacent fixing part andthe upper extension, preferably with an external polygon. The screwshaft is divided up into the externally threaded part, which is presentat the free end, and the attached cylindrical part. Between a first anda second cylindrical collar, the fixing part has an annular groove. Ifsleeve part and screw have been assembled to form the holding element,then the externally threaded part of the screw shank has firstly beenscrewed through the internally threaded section so that the externallythreaded part projects above the mating shoulder of the sleeve part andthe cylindrical part of the screw shaft then lies inside the internallythreaded section. Having been assembled in this way, the sleeve part isaxially displaceable between externally threaded part and the firstcollar which faces the latter.

When the holding element has been screwed onto an implant, the matingshoulder of the sleeve part rests in a complementary manner on theimplant shoulder and the first collar rests on the external polygonsegment. The externally threaded part of the screw shaft engages in theinternally threaded bore in the implant head.

The external polygon of the extension of the screw serves primarily togrip the holding element, which is connected to the implant head, bymeans of a screwing-in tool, in order to remove the implant from theampoule without direct contact, to transfer it to the site of use and toimplant it there. The annular groove on the fixing part of the screw isintended in particular to latch into engagement with a fixing part onthe ampoule, in order to retain the implant which is supported by theholding element in a releasable and suspended manner inside an ampoule.The external polygonal segment of the sleeve part is primarily providedfor the attachment of an unscrewing spanner when unlocking the holdingelement which has been screwed to the implant.

If the holding element is attached to the implant head as early asduring production of the implant, the holding element offers the optionof attaching manipulating members thereto for further processing of theimplant. This facilitates handling of the implants even during theirproduction.

In the widest ranging application and configuration, the holding elementis connected to the implant as early as during the production of thelatter, so that the following functions then emerge overall:

a) gripping and holding of the implant for the following productionphases; and

b) retaining of the implant inside an ampoule; and

c) attachment of a screwing-in tool for implanting the implant into thebone.

If the insertion of the implant into the bone per se has finished, thescrewing-in tool used can be pulled off the extension. The sleeve partwhich is resting fixedly on the implant shoulder is unlocked by means ofan unscrewing spanner, and then the screw is screwed out of theinternally threaded bore in the implant head, so that the holdingelement is detached from the implant.

The design features of the ampoule, which in principle is cylindrical,consist in the fact that it is open to the sides and has a fixing partin which the implant is held directly or indirectly. When removing theimplant from the ampoule, it is pulled out laterally. In an advantageousversion, the fixing part clamps in a holding element which is connectedto the implant head, so that the implant is supported by the holdingelement and does not come into contact with the wall of the ampoule. Ascrewing-in tool or an adapter for a screwing-in tool can be attacheddirectly to a free extension of the holding element, by means of whichscrewing-in tool or adapter the implant can be removed from the ampoulewithout contact. The ampoule can be inserted into a conventionalexternal capsule.

The holding element of the invention simplifies handling of the genericimplants during production and implantation itself. An implant can betaken hold of on the holding element and manipulating members andscrewing-in tools can be attached without problems and released again.In combination with the holding element, the effect is achieved that theampoule does not have to consist of the same material as the implant orcontain a specifically protective insert made of the implant material.The risks of contamination or damage to the implant surface areconsiderably reduced as a result of the form of the ampoule according tothe invention and the nature of suspension of the implant inside theampoule by means of the holding element. Furthermore, when the ampouleis tipped out of the outer capsule, it quickly comes to a halt on asterile surface on the operating table and no longer has a tendency toroll off, owing to the centre of gravity lying outside the longitudinalaxis. Finally, the ampoule, together with the implant, can be laid downstably, owing to the stand part situated opposite the fixing part, sothat attachment of the tools is facilitated.

BRIEF DESCRIPTION OF THE APPENDED DRAWINGS

With reference to the appended drawings, there now follows a detaileddescription of in each case one exemplary embodiment of the holdingelement according to the invention for the two types of implant and ofthe ampoule for storing the implant. Finally, possible modifications arementioned. In the figures:

FIG. 1A—shows a sectional illustration of the first type of a genericimplant in the form of a solid screw;

FIG. 1B—shows a sectional illustration of the first type of a genericimplant in the form of a hollow cylinder;

FIG. 1C—shows a sectional illustration of the first type of a genericimplant in the form of a hollow cylinder with an angled-off implanthead;

FIG. 1D—shows the second type of a generic implant in the form of asolid screw, as a perspective illustration;

FIG. 2A—shows a perspective view of a holding element according to theinvention having a sleeve part in a first version for the first type ofimplants in accordance with FIGS. 1A to 1C;

FIG. 2B—shows a front view, partially in section, of the holding elementin accordance with FIG. 2A;

FIG. 2C—shows a perspective view, partially in section, of the holdingelement in accordance with FIG. 2A;

FIG. 3A—shows a perspective view, partially in section, of the holdingelement in accordance with FIG. 2A, connected to an implant inaccordance with FIG. 1A;

FIG. 3B—shows a perspective view, partially in section, of the holdingelement having a sleeve part in a second version, connected to thesecond type of implants in accordance with FIG. 1D;

FIG. 4A—shows an ampoule according to the invention, in perspective viewonto the outside of the fixing part;

FIG. 4B—shows the ampoule in accordance with FIG. 4A, in perspectiveview onto the inside of the fixing part;

FIG. 4C—shows a front view, partially in section, of the ampoule inaccordance with FIG. 4A;

FIG. 4D—shows the ampoule in accordance with FIG. 4A, in plan view ontothe outside of the fixing part;

FIG. 5—shows the ampoule in accordance with FIG. 4A, with a holdingelement with a sleeve part in a first version in accordance with FIG. 2Aand an implant of the first type in accordance with FIG. 1A, surroundedby an external capsule, in longitudinal section;

FIG. 6A—shows a perspective view, partially in section, of a ratchetadapter which is known per se;

FIG. 6B—shows a front view, partially in section, of the ratchet adapterin accordance with FIG. 6A;

FIG. 7—shows a perspective view of an unscrewing spanner which is knownper se;

FIGS. 8A to 8J—show the principal handling operations for the ampoulesituated in an external capsule in accordance with FIG. 5, with animplant of the first type in accordance with FIG. 1A and a holdingelement in accordance with FIG. 2A as far as insertion of the implantinto the bone;

FIG. 8A—step 1—shows the initial situation; ampoule with implantretained by the holding element, surrounded by a closed externalcapsule, in longitudinal section in accordance with FIG. 5;

FIG. 8B—step 2—opening of the external capsule by removing the closurecover;

FIG. 8C—step 3—tipping the ampoule out of the external capsule;

FIG. 8D—step 4—preparation of the particular adapter for the alternativescrewing-in tools to be attached to the holding element;

FIG. 8E—step 5—removal of the implant with, attached to the holdingelement, either a ratchet adapter or a motor-driven, dental anglehandpiece;

FIG. 8F—step 6—shows the ratchet adapter attached as an alternative tothe holding element and insertion of the implant into the bone;

FIG. 8G—step 7—shows the screwing of the implant into the bone,alternatively by means of ratchet and guide spanner or by means of anglehandpiece;

FIG. 8H—step 8—shows removal of the guide spanner from the ratchetadapter after the screwing-in of the implant has been completed;

FIG. 81—step 9—shows the approach of the unscrewing spanner inaccordance with FIG. 7 towards the holding element for the purpose ofunlocking; and

FIG. 8J—step 10—shows the removal of the unscrewed holding element fromthe implant head.

EXEMPLARY EMBODIMENTS

The following statement applies to the whole of the rest of thedescription. If, for the sake of clarity of the drawing, a figurecontains reference numerals which are not explained in the immediatelyassociated text of the description, reference is made to where they arementioned in previous descriptions of figures; for the sake of clarity,repeated designation of components in following figures is generallydispensed with, as long as it can be clearly seen from the drawings thatthese are “recurring” components.

FIG. 1A

The implant 1 of the first type in this figure is in the form of a solidscrew and, at the top, has the implant head 10 which is widened in theform of a trumpet and at the top ends with the conical implant shoulder11. The implant shoulder 11 surrounds a conical bore 12 which opens outhere, widens outwards and as a threaded bore 14 continues furtherdownwards beneath the base of the bore 13. Towards the apical end, theroot part 15, which has the external screw thread 16, ends with theimplant tip 17 and is intended to be inserted into the bone, extendsbeneath the implant head 10. The threaded bore 14 serves to accommodatethe threaded part of an abutment (not shown), while the conical bore 12accommodates the conical nose of the abutment. The implant 1 usuallyconsists of titanium and on the outside has an implant casing 18 with aspecial surface structure promoting bone integration.

FIGS. 1B and 1C

The implant in accordance with FIG. 1B is a hollow cylinder, the rootpart 15 of which is hollow and, in the implant casing 18, has aplurality of continuous, peripheral bone-integration holes 19, whichallow the regenerating bone to grow through them, leading to fixedanchorage in the bone. The hollow cylinder does not have an externalscrew thread, but also has the special surface structure on the outsideof the implant casing 18. The implant 1 in accordance with FIG. 1Cdiffers from the hollow cylinder shown in FIG. 1B only by the fact thatthe implant head 10 is angled off with respect to the root part 15.

FIG. 1D

This single-piece implant 1′ of the second type in this case is in theform, for example, of a solid screw and differs from the configurationin accordance with FIG. 1A only with regard to the condition of theimplant head 10′. In the second type, the conical bore 12, the bore base13 and the threaded bore 14 are absent. However, analogously to thefirst type, the implant shoulder 11′, the root part 15′, the externalscrew thread 16′, the implant tip 17′ and the implant casing 18′ arepresent. Instead of the internal configuration with the conical bore 12,the second implant type 1′ has a male segment 12′ which projects abovethe implant shoulder 11′, emerges axially and centrally from the implant1′ and tapers conically in the direction away from the implant 1′. Anon-rotationally symmetrical contour 13′ in the form of an externalpolygon, is present on the segment 12′ for the purpose of positioningfurther attachments. Preferably, the non-rotationally symmetricalcontour 13′ is situated at the transition to the implant shoulder 11′.For further implant additions, the segment 12′ has an axial threadedbore 14′.

FIGS. 2A to 2C

The holding element 100 depicted is provided for the first implant type1 having the conical bore 12. A sleeve part 102 and a rotatable screw101, which projects through the sleeve part 102 and is axially movableto a limited extent, form the two constituents of the holding element100. At the bottom, the sleeve part 102 has a cylindrical shoulder part160, which ends with a downwardly directed mating shoulder 161 which iscomplementary to the implant shoulder 11. An external polygonal segment170 extends axially upwards from the shoulder part 160. An axial bore162 with an internally threaded section 163 allowing the passage of theshaft 130 of the screw 101 runs through the sleeve part 102.

The screw shaft 130 is adjoined by a fixing part 110, and the latter isadjoined in turn by the extension 120, which ends at the top and has anexternal polygon 121. The screw shaft 130 is divided into the externallythreaded part 131, which is present at the free end, and the attachedcylindrical part 132. The fixing part 110 has a first cylindrical collar114 and a second cylindrical collar 118, between which there lies acylindrical section 116 of reduced diameter. The collars 114, 118 arewidened with respect to the diameter of the screw shaft 130. At thetransition between the cylindrical part 132 and the first collar 114, aconical shoulder 113 is formed, which is intended to bear axially, inthe form of a circle and in a positively locking manner against theupper conical support shoulder 171 on the external polygonal segment170. Annular shoulders 115,117 are produced at each of the transitionsbetween the cylindrical section 116 and the first and second collars114,118. The cylindrical section 116, together with the two adjoiningannular shoulders 115,117, forms the fixing part 110 of the holdingelement 100. The peg-like extension 120 has the external polygon 121 asits non-rotationally symmetrical contour, onto which a tool, e.g. ascrewing-in tool, can be attached. To impede the plug connection betweenthe external polygon 121 and the adapted tool, a radial groove 123 ispresent on the extension 120, between the second collar 118 and theexternal polygonal segment 170, in order to arrange a securingelement—preferably an O-ring—therein.

In order to assemble the sleeve part 102 and screw 101 to form theholding element 100, the externally threaded part 131 of the screw shaft130 has to be screwed through the internally threaded section 163, sothat the externally threaded part 131 projects beyond the matingshoulder 161 of the sleeve part 102 and the cylindrical part 132 of thescrew shaft 130 then lies inside the internally threaded section 163.Having been assembled in this way, the sleeve part 102 is axiallydisplaceable between externally threaded part 131 and the first collar114 which faces the latter.

FIG. 3A

When the holding element 100 has been screwed onto an implant 1—in thiscase an implant 1 of the first type and hence a corresponding holdingelement 100 in the first version, —the mating shoulder 161 of theshoulder part 160 of the sleeve part 102 fits on the implant shoulder 11and the conical shoulder 113 of the first collar 114 rests on thesupport shoulder 171 of the external polygonal segment 170. Theexternally threaded part 131 of the screw shaft 130 of the screw 101engages in the internally threaded bore 14 in the implant head 10 andthe unthreaded cylindrical part 132 of the screw shaft 130 penetratesthrough the internally threaded section 163 inside the sleeve part 102.

FIG. 3B

In this figure, an implant 1′ of the second type—having a male segment12′ projecting above the implant shoulder 11′—is connected to anassociated holding element 100′ of the second version. In order toaccommodate the segment 12′ inside the shoulder part 160′, the latter iselevated by comparison with the first version and the axial bore 162′,which passes through the sleeve part 102′, is widened in the region ofthe shoulder part 160′. Otherwise, this arrangement is analogous to thatin accordance with FIG. 3A; thus the mating shoulder 161′ of theshoulder part 160′ of the sleeve part 102′ again fits on the implantshoulder 11′ and the conical shoulder 113 of the first collar 114 restson the support shoulder 171′ of the external polygonal segment 170′. Theexternally threaded part 131 of the screw shaft 130 of the screw 101 isin engagement with the internally threaded bore 14′, which extends fromthe segment 12′ into the implant head 10′. The unthreaded cylindricalpart 132 of the screw shaft 130 penetrates through the internallythreaded section 163′ inside the sleeve part 102′.

Advantageously, the holding element 100,100′ is connected to the implant1,1′ as early as during production of the latter, so that the holdingelement 100,100′ even during the following production phases offers theoption of attaching manipulation members to it or of being used as asupport when positioning the implants in devices. The extension 120 andthe fixing part 110 are suitable for the attachment of manipulationmembers. Since the sleeve part 102,102′ is placed upon the implant 1,1′,the two preferably consist of the same material, e.g. titanium, while,for example, stainless steel is recommended as the material for thescrew 101.

FIGS. 4A to 4D

The ampoule 200, which is in principle cylindrical, for accommodating animplant 1,1′ has a fixing part 210 on the first planar base side and astand part 220 on the opposite, second planar base side. The cylindricalcasing 230 extends between the fixing part 210 and the stand part 220,in which casing there is a large-area cutout 231 which runs from thefixing part 210 as far as the stand part 220 and extends, for example,over a quarter to a half of the radial circumference of the ampoule 200.The implant 1,1′ which is held in the ampoule 200 can be pulled outthrough this lateral cutout 231. Thus the cylindrical casing 230 whichremains in the region of the cutout 231 is in the form of an open shell232, while in the stand part 220 the cylindrical casing 230 is entirelyretained, where it produces, as it were, a tubular section 221. Thesecond planar base side is preferably open.

The cutout 231 extends as far as the fixing part 210, which is in theform of a circular end plate, so that the associated first planar baseside is largely closed and the cylindrical casing 230 is perpendicularto the fixing part 210. A laterally open indent 212 is situated in thefixing part 210, this indent 212, together with the cutout 231, facingin the same direction. The indent 212 is in principle in the form of aslot with rounded sections 218 at the peripheral entry. In the region ofthe theoretical centre axis M the indent 212 has a constriction 213,behind which the indent 212 widens in the manner of a semicircle. Theresult is two mutually opposite jaws 215,216 on the fixing part 210.Beyond the indent 212, cutting further into the fixing part 210 towardsthe cylindrical casing 230, there is an expansion groove 217, so thatwhen an implant 1,1′ or a holding element 100,100′ bearing the implant1,1′ is being pressed in and out between the jaws 215,216, the latterare better able to spread apart elastically. When the holding element100,100′ is being pressed in, after its cross-section has overcome theconstriction 213, the holding element 100,100′ latches into the indent212 and the jaws 215,216 move closer together again.

Owing to the asymmetric distribution of material, the centre of gravityof the ampoule 200 lies outside the centre axis M, so that an ampoule200 which is lying horizontally and hence rolling to and fro quicklycomes to a halt. In order additionally to prevent the ampoule 200 fromrolling off the surface, in each case one bead 233 is provided on theoutside of the cylindrical casing 230, in an axial position and parallelto the edges of the cutout 231. The plane which extends between the twobeads 233 divides the tubular ampoule 200 into two longitudinal halves.With the stand part 220 at the bottom, the ampoule 200 can be placedvertically resting on the second planar base side. A suitable materialfor the ampoule 200 is a biocompatible plastic.

FIG. 5

This Figure is described with reference to the implant 1 and the holdingelement 100. Analogously, it would also be possible to use the implant1′ of the second type in conjunction with a holding element 100′ of thesecond version.

In the finished state, the ampoule 200, with the implant 1 held thereinby the holding element 100, is inserted into an external capsule 300.The external capsule 300 comprises a hollow cylinder 310, the base 311of which is closed, and a screw-on closure cap 320. On the inside of thecylinder 310, parallel to and at a distance from the base 311, there isa support shoulder 313, which is intended to act as an axial stop forthe first planar base side on the fixing part 210 of the insertedampoule 200. In this case, the support shoulder 313 comprises four webswhich are offset through 90° in each case. The closure cap 320 pointstowards the stand part 220 of the ampoule 200. At most in the region ofthe clearance between the second planar base side on the stand part 220and the closure cap 320, the ampoule 200 can move on the axis M andotherwise lies in a stable position in the external capsule 300 in theevent of vibrations.

The implant 1 is held by a holding element 100 with the screw 101 andthe sleeve part 102. As has already been indicated, the externallythreaded part 131 of the screw 101, which projects through the sleevepart 102, engages in the internally threaded bore 14 on the implant 1,while the mating shoulder 161 of the shoulder part 160 of the sleevepart 102 rests on the implant shoulder 11. The fixing part 110 of theholding element 100 is latched into the fixing part 210 of the ampoule200, i.e. the cylindrical section 116 of the holding element 100 isclamped in the indent 212 in the ampoule 200 and is surrounded laterallyby the two jaws 215,216. The two annular shoulders 115,117 of theholding element 100 bear against the fixing part 210 on both sides. Inthis way, the implant 1 is held in line with the centre axis M insidethe ampoule 200 without coming into contact with the ampoule 200.

FIGS. 6A and 6B

The ratchet adapter 400 which can be attached to the extension 120 ofthe holding element 100,100′ comprises the head part 401 and the shankattachment 402. The head part 401 has the outer profiling 430 which iscomplementary to a ratchet wrench and, on the end side, has an axialblind bore 431 for accommodating the pin of an unscrewing spanner. Onthe inside, the shank extension 402 has an internal polygon 410 which iscomplementary to the external polygon 121. On the outside, ahead of theinternal polygon 410, there is a constriction 411 which reduces theclear diameter, so that a widened annular groove 412 is formed betweenthe internal polygon 410 and the constriction 411. The annular groove412 serves to accommodate a securing element which rests in the radialgroove 123 on the extension 120 after the said securing element hasovercome the constriction 411 when the ratchet adapter 400 is attached.As a result, the ratchet adapter 400 can, as it were, be latched ontothe extension 120 and cannot become detached of its own accord.

FIG. 7

For handling purposes, an unscrewing spanner 700 is also provided, whichserves to grip the external polygonal segment 170,170′ on the sleevepart 102, 102′ of the holding element 100,100′. At one end, theunscrewing spanner 700 is designed as an angled-off open-end wrench 701,and at the other end as a straight ring wrench 702. A guide pin 704 issituated on the flat side 703 in the region of the ring wrench 702.Whether the open-end wrench or the ring wrench 701,702 is employeddepends on the spatial conditions and the preference of the user.

FIGS. 8A to 8J

The step-by-step handling of the ampoule 200 is explained in connectionwith the following sequence of figures, using, by way of example, animplant 1 and a holding element 100.

Step 1 (FIG. 8A): In the finished state, the ampoule 200 is positionedin the closed external capsule 300 comprising the cylinder 310 and theclosure cap 320. The holding element 100 holds the implant 1 and, forits part, is fixed by the ampoule 200 in the indent 212. The entirecontents of the external capsule 300 are sterile.

Step 2 (FIG. 8B): In order to open the external capsule 300, the closurecap 320 is removed from the cylinder 310.

Step 3 (FIG. 8C): The ampoule 200, with the implant 1 contained therein,is tipped out of the cylinder 310, which is now open, of the externalcapsule 300 onto a sterile surface.

Step 4 (FIG. 8D): The extension 120 with the external polygon 121projects out of the ampoule 200. To attach screwing-in tools—namely aratchet wrench or a dental handpiece—a ratchet adapter 400 or an adapter450 for the dental handpiece are kept ready. At one end, the adapter 450has a standard dental coupling 451 and, opposite to the latter, a shankattachment 452, which is likewise intended for attachment to theextension 120 and has an internal structure which is analogous to theshank extension 402 of the ratchet adapter 400.

Step 5 (FIG. 8E): Depending on the screwing-in tool to be used, theratchet adapter 400 or the adapter 450 for the dental handpiece 800 isattached to the extension 120 and the implant 1 is removed from theampoule 200. The implant 1, which is suspended from the ratchet adapter400 or from the adapter 450 and from the handpiece 800 by means of theholding element 100 is transferred to the location of use.

Step 6 (FIG. 8F): When using a ratchet spanner as the screwing-ininstrument, the ratchet adapter 400 will first be taken hold of by handand the implant 1 will be screwed to some extent into the bore KB whichhas been prepared in the bone K.

Step 7 (FIG. 8G): To screw the implant 1 in further, a ratchet wrench600 and an unscrewing spanner 700 are placed upon the ratchet adapter400. The guide pin 704 of the unscrewing spanner 700 engages in theblind bore 431. The implant 1 can also be screwed in by means of amotor-driven dental handpiece 800, as long as the associated adapter 450has in advance been placed upon the holding element 100.

Step 8 (FIG. 8H): After screwing using a ratchet wrench 600 has beencompleted, the unscrewing spanner 700 is removed from the ratchet wrench600.

Step 9 (FIG. 81): Irrespective of whether the implant has been insertedusing ratchet wrench 600 or by means of handpiece 800, in order tounscrew the holding element 100, i.e. firstly to unlock the sleeve part102 from the implant head 10, the unscrewing spanner 700 is attached tothe external polygonal segment 170. The open-end wrench 701 can beattached to the external polygonal segment 170 from the side. Whenattaching the ring wrench 702, which is carried out from above, it wouldfirst be necessary briefly to remove the screwing-in instrument 600,800,together with the associated adapters 400,450, from the extension 120 ofthe holding element 100. With the operating direction of the ratchetwrench 600 or handpiece 800 switched over and the unscrewing spanner 700attached, the holding element 100 is unlocked from the implant 1. Theunscrewing spanner 700 is then removed and the screw 101 is unscreweduntil its externally threaded part 131 comes out of engagement with theinternal screw thread 14 in the implant head 10.

Step 10 (FIG. 8J): Finally, the holding element 100 can be removed fromthe implant 1, which is now in situ.

Further design variations on the devices described above are possible.Express mention may be made of:

The holding element 100,100′ can also be used for implants of differentconfiguration. The important criterion is that the implants have aninternally threaded bore 14 which is accessible from the outside inorder for the externally threaded part 131 of the holding element 100 tobe screwed in. Furthermore, the implants must have an implant shoulder11 or a comparable surface for supporting the sleeve part 102.

Instead of the external polygon 121 on the screw 101, a different,external, non-rotationally symmetrical contour on the extension 120,120′is conceivable, as is an internal contour, if the tools to be attachedwere to have a complementary mandrel.

The jaws 215,216 on the ampoule 200 could generally be replaced by aclamping member.

For implants 1,1′ with a conically widening implant head 10,10′ risingbeneath the implant shoulder 11,11′, the following attachment for theholding element is provided as an alternative. In the case of the screw101 which engages in the internally threaded bore 14,14′ in the implant1,1′, the screw shaft 130, together with the externally threaded part131 and cylindrical part 132, could be dispensed with. Sleeve part102,102′ and screw extension 120 would then form a single part. Thetemporary fixing of the holding element on the implant 1,1′ is thenrealized by means of an elastic snap-in element at the bottom of thesleeve part 102,102′ which, when pressed onto the implant shoulder11,11′, passes over the latter and then engages below it. This method ofattaching the holding element is particularly expedient if the implant1′ has a polygonal segment 12′ which projects above the implant shoulder11′, and/or if no internally threaded bore 14,14′ is present. In thisregard, reference is made to the attachment in accordance with thepatent publication WO-A-97 28755 of the applicant.

What is claimed is:
 1. In a holding element (100, 100′) for an implant(1, 1′) which is adapted to be inserted into bone (K) and has an implanthead (10, 10′), an implant shoulder (11, 11′) present thereon, and aninternally threaded bore (14, 14′), which extends at least substantiallyin the axial direction, in which a) the holding element (100, 100′)comprises a sleeve part (102, 102′) and a rotatable screw (101) whichprojects through the sleeve part (102,102′); b) the sleeve part (102,102′) has, at the bottom, a cylindrical shoulder part (160, 160′) whichterminates with a mating shoulder (161, 161′) which is directeddownwards and is complementary to the implant shoulder (11, 11′) c) anupwardly directed external polygon segment (170, 170′) extends above theshoulder part (160, 160′); d) an axial bore (162, 162′) allowing thepassage of the shaft (130) of the screw (101) extends through the sleevepart (102, 102′); e) an external threaded part (131) of the screw shaft(130) is adapted to engage in the internally threaded bore (14, 14′) inthe implant (1, 1′); f) the screw (101) has an extension (120), whichprojects above the sleeve part (102, 102′) and has a non-rotationallysymmetrical contour (121), for the attachment of a tool; the improvementwherein g) the holding element (100, 100′) is screwed to the implant (1,1′) already during the production of said implant (1, 1′) and isutilized with said implant (1, 1′) during further implant productionphases, up to and including implantation; and h) a fixing part (110) isprovided between the contour (121) and the sleeve part (102, 102′),which fixing part (110) serves for the attachment of a manipulationmember in a device for operating, transportation, storage purposes andfor retention inside an ampoule (200).
 2. The holding element (100,100′) according to claim 1, wherein: a) an internally threaded section(163, 163′), which is complementary to the externally threaded part(131) of the screw shaft (130), is present in the axial bore (162,162′); and b) above the externally threaded part (131) situated at thefree end, the screw shaft (130) has a cylindrical part (132) which isslidable within the internally threaded section (163, 163′), so that thescrew (101) which has been screwed into the sleeve part (102, 102′) ismovable axially to a limited extent.
 3. The holding element (100, 100′)according to claim 1 or 2, wherein: a) the fixing part (110) is formedby two collars (114, 118) which are spaced apart from one another and acylindrical section (116) which lies between these two collars (114,118) and has a reduced diameter in comparison with the collars (114,118); such that b) an annular shoulder (115, 117) is formed at each ofthe transitions from the cylindrical section (116) to each of thecollars (114, 118); c) the non-rotationally symmetrical contour (121) onthe extension (120) of the screw (101) is an external polygon (121); d)a radial groove (123) for accommodating a securing element is providedbetween the external polygon (121) and the adjoining collar (118); ande) the collar (114) which faces towards the sleeve part (102, 102′) hasa conical shoulder (113) which comes to bear against a complementarysupport shoulder (171, 171′) on the sleeve part (102, 102′).
 4. Anampoule (200) for transporting, storing and providing an implant (1, 1′)directly before its insertion into the bone (K), which ampoule (200) hasan outer cylindrical casing (230) and is insertable into an externalcapsule (300), the ampoule (200) comprising: a) a fixing part (210),into which the implant (1, 1′) is insertable indirectly; and b) alateral, large-area cutout (231) in the casing (230), through whichcutout (231) the implant (1, 1′), which is held inside the ampoule(200), is removable.
 5. The ampoule (200) according to claim 4, wherein:a) the fixing part (210) forms a planar base side of the cylindricalampoule (200); and b) a laterally open indent (212), for the indirectclamping accommodation of the implant (1, 1′), is situated in the fixingpart (210), which indent (212) faces in the same direction as the cutout(231).
 6. The ampoule (200) according to claim 4 or 5, wherein theindent (212) has: a) outwardly facing rounded sections (218); b) aconstriction (213), behind which the indent (212) widens again, in theregion of a theoretical centre axis (M) of the ampoule (200); and c) anexpansion groove (217), which extends the indent (212) toward thecylindrical casing (230).
 7. The ampoule (200) according to claim 4 or5, wherein: a) a stand part (220), for standing the ampoule (200)vertically, lies opposite the fixing part (210), which is situated atone end of the ampoule (200), at the other end of the ampoule (200); andb) the cutout (231) terminates before the stand part (220), such thatthe casing (230) forms a radially continuous tubular section (221). 8.The ampoule (200) according to claim 4, wherein: a) owing to anasymmetric distribution of material, the centre of gravity of theampoule (200) lies outside a theoretical centre axis (M) of the ampoule(200), in order rapidly to decelerate a rolling movement of the ampoule(200); and b) two beads (233), which extend axially on either side ofthe cutout (231) and serve as an additional protection against theampoule (200) rolling away, are provided outside the cylindrical casing(230).
 9. The ampoule (200) according to claim 4, wherein said ampoule(200) is sized and shaped to receive an implant (1, 1′) which is adaptedto be inserted into bone (K) and which has an implant head (10, 10′), animplant shoulder (11, 11′) present thereon, and an internally threadedbore (14, 14′), which extends at least substantially in the axialdirection, in which a) a holding element (100, 100′) is provided, whichcomprises a sleeve part (102, 102′) and a rotatable screw (101) whichprojects through the sleeve part (102, 102′); b) the sleeve part (102,102′) has, at the bottom, a cylindrical shoulder part (160, 160′) whichends with a mating shoulder (161, 161′) which is directed downwards andis complementary to the implant shoulder (11, 11′); c) an upwardlydirected an external polygon segment (170, 170′) extends above theshoulder part (160, 160′); d) an axial bore (162, 162′) allowing thepassage of the shaft (130) of the screw (101) extends through the sleevepart (102, 102′); e) an external threaded part (131) of the screw shaft(130) is adapted to engage in the internally threaded bore (14, 14′) inthe implant (1, 1′); f) the screw (101) has an extension (120), whichprojects above the sleeve part (102, 102′) and has a non-rotationallysymmetrical contour (121), for the attachment of a tool; and wherein g)a fixing part (110), which projects above the sleeve part (200, 200′)and serves for retaining purposes inside the ampoule (200), is providedbeneath the contour (121); h) the fixing part (110) of the holdingelement (100, 100′) is adapted to be latched into the fixing part (210)of the ampoule (200), so that i) the holding element (100, 100′), whichhas been fixed in the ampoule (200), holds the implant (1, 1′), which isscrewed to the holding element (100, 100′), inside the ampoule (200) andin line with a theoretical centre axis (M) of the ampoule (200).
 10. Theampoule (200) according to claim 9, wherein: a) the fixing part (110) ofthe holding element (100, 100′) comprises two collars (114, 118), whichare spaced apart from one another, and a cylindrical section (116) whichlies between the collars (114, 118) and is of reduced diameter incomparison with the collars (114, 118); b) an annular shoulder (115,117) is formed at each of the transitions from the cylindrical section(116) to the collars (114, 118); and c) in the completed arrangement,with the implant (1, 1′) inserted into the ampoule (200), thecylindrical section (116) being clamped into the indent (212) in thefixing part (210) of the ampoule (200), each of the annular shoulders(115, 117), respectively, bears against one side of the fixing part(210) of the ampoule (200).
 11. The ampoule (200) according to claim 4,wherein axial retention of the ampoule (200), which has been insertedinto the external capsule (300), is achieved by means of a closure cap(320), which belongs to the external capsule (300), and a supportshoulder (313), which is arranged inside the external capsule (300), inthe region of the base (311) of said external capsule (300), and onwhich the end side of the fixing part (210) of the ampoule (200) issupported.
 12. The ampoule (200) according to claim 4, wherein: a) thefixing part (210) forms a planar base side of the cylindrical ampoule(200); and b) a laterally open indent (212), for the direct clampingaccommodation of the implant (1, 1′), is situated in the fixing part(21), which indent (212) faces in the same direction as the cutout(231).
 13. An ampoule (200) for transporting, storing and providing animplant (1, 1′) directly before its insertion into the bone (K), whichampoule (200) has an outer casing (230) and is insertable into anexternal capsule (300), the ampoule (200) comprising: a) a fixing part(210), into which the implant (1,1′) is insertable directly; and b) alateral, large-area cutout (231) in the casing (230), through whichcutout (231) the implant (1, 1′), which is held inside the ampoule (200)is removable.